Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Darolutamide + ADT Combined with Low-dose Docetaxel.
- Who it may be relevant to
- Registry conditions: mHSPC. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC: a Multi-center, Prospective, Single-arm Study
Overview
This is a single-arm, prospective, multicenter, interventional study, aimed at exploring the efficacy and safety of darolutamide + ADT combined with low-dose docetaxel in treating patients with mHSPC planning to recruit approximately 109 patients. The purpose of this study is to investigate the proportion of patients who reach PSA undetectable (PSA\< 0.2ng/ml) at the primary analysis (24 weeks). According to the ARASENS study, the percentage of undetectable PSA in the experimental arm in the Chinese subset at 24 weeks is 46.2%. This study calculates that it is possible to maintain the therapeutic efficacy of PSA while reducing the dose of docetaxel.
Interventions
- Drug Darolutamide + ADT Combined with Low-dose Docetaxel
1. Darolutamide This study used Darolutamide from Bayer Pharmaceuticals, with a specification of 300mg per tablet. The dose is 600 mg （2 tablets）, taken twice a day with meals. 2. Docetaxel The dose of docetaxel is 60mg/m2, administered intravenously on the first day of each cycle. This cycle should be repeated every 3 weeks for a maximum of 6 cycles. Docetaxel can be administered in combination with prednisone/prednisolone at the discretion of the researcher. To prevent hypersensitivity and fl
Primary outcome measures
- Undetectable PSA(<0.2ng/ml) at 24w [Time frame: 6 months]
- Undetectable PSA(<0.2ng/ml) at 24w [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Written informed consent
- Males ≥18 years of age
- Histologically or cytologically confirmed adenocarcinoma of prostate
- Metastatic disease documented either by a positive bone scan, or for soft tissue or visceral metastases, either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by Investigator and confirmed by central radiology review
- Subjects must be candidates for ADT and docetaxel therapy per Investigator's judgment
- Started ADT (LHRH agonist/antagonist or orchiectomy) with or without first generation anti-androgen, but no longer than 12 weeks before included. For subjects receiving LHRH agonists, treatment in combination with a first generation anti-androgen for at least 4 weeks before the initiation of study is recommended. First generation anti-androgen has to be stopped prior to included.
- An Eastern Cooperative Oncology Group performance status of 0 or 1
Exclusion criteria
1\. Prior treatment with:
- LHRH agonist/antagonists started more than 12 weeks before before the initiation of study
- Second-generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, darolutamide, other investigational AR inhibitors
- Cytochrome P 17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer
- Chemotherapy or immunotherapy for prostate cancer prior to randomization 2. Treatment with radiotherapy (external beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before initiation of study 3. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Affiliated Cancer Hospital of Guangzhou Medical University — Guangzhou
- Meizhou People's Hospital — Meizhou
Publications
- Kamiya N, Suzuki H, Ueda T, Sato N, Nakatsu H, Mikami K, Sato N, Nomura K, Akakura K, Okano T, Ooki T, Naya Y, Ota S, Masai M, Ichikawa T. Clinical outcomes by relative docetaxel dose and dose intensity as chemotherapy for Japanese patients with castration-resistant prostate cancer: a retrospective multi-institutional collaborative study. Int J Clin Oncol. 2014 Feb;19(1):157-64. doi: 10.1007/s1014 PMID 23299278
- Smith MR, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford ED, Kopyltsov E, Park CH, Alekseev B, Montesa-Pino A, Ye D, Parnis F, Cruz F, Tammela TLJ, Suzuki H, Utriainen T, Fu C, Uemura M, Mendez-Vidal MJ, Maughan BL, Joensuu H, Thiele S, Li R, Kuss I, Tombal B; ARASENS Trial Investigators. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022 Mar 24;386 PMID 35179323
- Jimenez N, Garcia de Herreros M, Reig O, Marin-Aguilera M, Aversa C, Ferrer-Mileo L, Garcia-Esteve S, Rodriguez-Carunchio L, Trias I, Font A, Rodriguez-Vida A, Climent MA, Cros S, Chirivella I, Domenech M, Figols M, Carles J, Suarez C, Herrero Rivera D, Gonzalez-Billalabeitia E, Civico C, Sala-Gonzalez N, Ruiz de Porras V, Ribal MJ, Prat A, Mellado B. Development and Independent Validation of a Pr PMID 38429210
Identifiers
NCT: NCT07503379 · 2025-FXY-342